NCT05084924: DEBRA

Investigating the Causal Role of Prefrontal Control in Decision-making in Patients With Anhedonia

Completed NA Results posted Last updated 25 June 2024

What this trial tests

NA trial testing Cross-frequency transcranial alternating current stimulation via the NeuroConn Direct Current Stimulator Plus in Major Depressive Disorder in 35 participants. Completed in 31 July 2023.

Timeline

2 November 2021

Primary endpoint
31 July 2023

31 July 2023

Quick facts

Lead sponsor	University of North Carolina, Chapel Hill
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	basic science
Enrollment	35
Start date	2 November 2021
Primary completion	31 July 2023
Estimated completion	31 July 2023
Sites	1 location across United States

Drugs / interventions tested

• Cross-frequency transcranial alternating current stimulation via the NeuroConn Direct Current Stimulator Plus

Conditions studied

• Major Depressive Disorder — all drugs for Major Depressive Disorder →
• Anhedonia — all drugs for Anhedonia →

Sponsor

University of North Carolina, Chapel Hill

Who can join

Adults 18 to 65, any sex, with Major Depressive Disorder or Anhedonia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in the Percentage of Trials That the Participant Chooses to Perform the Hard Task Primary · Baseline (Hour 1), Stimulation (Hours 2 through 3)

In the Expenditure of Effort for Reward Task, participants are faced with a decision on every trial: to choose an easy task with a low effort exertion for a chance at winning a low amount of money or a hard task with a high effort exertion for a chance at winning a greater amount of money. The incentive for the high effort exertion is changed on each trial and the participant gets physically tired from repeated effort exertion. Goal-directed behavior was calculated as the percentage of trials in which the participant decides to perform the high effort exertion. The average of the 4 blocks prio

Group	Value	95% CI
Delta-beta tACS	-0.30	± 0.15
Theta-gamma tACS	-0.22	± 0.12
Active-sham tACS	-0.09	± 0.29

Change in Coupling Strength Between Low-frequency Prefrontal Signals and High-frequency Posterior Signals Secondary · Baseline (Hour 1), Stimulation (Hours 2 through 3)

Coupling strength was estimated using the Mean Vector Length calculation between the phase of low-frequency electrical activity in prefrontal electrodes and amplitude of high-frequency activity in posterior cortex. A hybrid signal was created using high-frequency amplitude and low-frequency phase. The magnitude of the average of this signal over time is the coupling strength. Coupling strength was normalized using a z-transformation relative to a null distribution generated by randomly time-shifting the high-frequency data relative to the low-frequency data (z-score). A value of zero represent

Group	Value	95% CI
Delta-beta tACS	0.95	± 0.68
Theta-gamma tACS	-0.97	± 1.04
Active-sham tACS	0.13	± 1.78

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 week. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Delta-beta tACS

Serious: 0/11 (0%)

Deaths: 0/11

Theta-gamma tACS

Serious: 0/12 (0%)

Deaths: 0/12

Active-sham tACS

Serious: 0/12 (0%)

Deaths: 0/12

Other adverse events (12 terms — click to expand)

Reaction	System	Delta-beta tACS	Theta-gamma tACS	Active-sham tACS
Sleepiness	General disorders	—	—	—
Flickering Lights	Eye disorders	—	—	—
Scalp Pain	Skin and subcutaneous tissue disorders	—	—	—
Trouble Concentrating	General disorders	—	—	—
Headache	Nervous system disorders	—	—	—
Neck Pain	Musculoskeletal and connective tissue disorders	—	—	—
Tingling	Skin and subcutaneous tissue disorders	—	—	—
Burning Sensation	Skin and subcutaneous tissue disorders	—	—	—
Local redness	Skin and subcutaneous tissue disorders	—	—	—
Change in mood	Psychiatric disorders	—	—	—
Ringing in ear	Ear and labyrinth disorders	—	—	—
Dizziness	Nervous system disorders	—	—	—

Data from ClinicalTrials.gov NCT05084924 adverse events section.

Sponsor's own description

Investigating whether delta-beta cross-frequency transcranial alternating current stimulation can increase goal-directed behavior in participants with major depressive disorder and elevated symptoms of anhedonia.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Transcranial alternating current stimulation for neuropsychiatric disorders: a systematic review of treatment parameters and outcomes.
   Gholamali Nezhad F, Martin J, Tassone VK, Swiderski A, et al · · 2024 · cited 7× · PMID 39211537 · DOI 10.3389/fpsyt.2024.1419243
2. Causal Evidence for Prefrontal-Motor Coupling in Reward-Responsive Goal-Directed Behavior.
   Riddle J, Edwards LP, Smoski M, Schiller CE, et al · · 2026 · cited 1× · PMID 41611533 · DOI 10.1523/jneurosci.1289-25.2026
3. ACNP 62nd Annual Meeting: Poster Abstracts P251 – P500
   · 2023
4. ACNP 61^st Annual Meeting: Poster Abstracts P1 - P270.
   · 2022 · PMID 36456693 · DOI 10.1038/s41386-022-01484-1